Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study

NCT ID: NCT05914350

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-23
• Study Completion Date: 2025-03-23

Brief Summary

Comparison between ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis; a Randomized Double Blinded Controlled Study

Detailed Description

The sacroiliac joints (SIJ) are the largest axial joints in the human body. By aging, osteoarthritic degeneration occurs to SIJ. SIJ dysfunction typically results from abnormal motion and malalignment of the joint (1).

SIJ pain is one of the differential diagnoses of low back pain. Approximately, 10-25% of these patients will have SIJ dysfunction which should be considered clinically (1, 2). This pain affects physical, psychological and social aspects of the person reducing the work performance. It imposes a huge burden on nations globally (3, 4).

SIJ pain can be a difficult condition to treat and a multidisciplinary approach to treatment including multimodal medical, psychological, physical, and interventional approach is recommended (5).

Corticosteroids are a very magic therapy since their first use and they offer anti-inflammatory mechanisms to reduce low back pain and joint pain. SIJ steroid injections are typically performed for SIJ pain related to osteoarthritis, ligamentous sprain and sacroiliitis associated with inflammatory spondyloarthropathies (5, 6).

Intra-articular steroid injections have intermediate-term benefits, in which more than half of the patients had positive responses to treatment in a 6-month follow-up (7, 8).

Another treatment modality is Platelet-rich plasma (PRP) which is autologous blood that contains platelet concentrations above normal physiological levels (9). PRP is believed to stimulate regeneration through the release of growth factors and proteins that may be involved in repairing the degeneration (10, 11).

While corticostroid injection has rapid onset of pain releif with short duration, the PRP injection has delayed onset and long term of pain releif in recent studies (12-14).

Ozone therapy has been used in the treatment of many musculoskeletal diseases including low back pain (LBP), lumbar disk herniation, cervical pain, cervical disk herniation, failed back surgery syndrome, degenerative spinal disease, knee osteoarthritis, meniscal injuries, sacroiliitis, plantar fasciitis and carpal tunnel syndrome (8, 15). However, ozone therapy is not tested well in SIJ. Ozone has multiple mechanisms of action:, antioxidant, analgesic and antiinflammatory effects (16, 17).

Ultrasound has gained increasing popularity in pain management (18). Furthermore, it is a valuable tool for pain physicians in confirming the diagnosis of many musculoskeletal pain conditions (19). It has many advantages when compared to fluoroscopy techniques (20). It has no radiation exposure, procedures can be done outside operating room which will decrease the costs (21).

Conditions

the Efficacy of Ultrasound Guided Sacroiliac Injection of Ozone, Platelet Rich Plasma (PRP) or Steroid for Treatment of Sacroiliitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group 1

40 mg methylprednisolone acetate and 1 mL lidocaine will be injected in sacroiliac joint in first week by ultrasound. While the second and third injections in the second and third weeks will be done by sham injection

Group Type: EXPERIMENTAL

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

Intervention Type: PROCEDURE

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

methylprednisolone acetate and lidocaine

Intervention Type: DRUG

40 mg methylprednisolone acetate and 1 mL lidocaine

Group 2

3 mL PRP and 1 mL lidocaine will be injected in sacroiliac joint by ultrasound once/week for 3 weeks

Group Type: EXPERIMENTAL

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

Intervention Type: PROCEDURE

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

PRP and lidocaine

Intervention Type: DRUG

3 mL PRP and 1 mL lidocaine

Group 3

10 ml of medical ozone of 20 μg/ml will be injected in sacroiliac joint by ultrasound once/week for 3 weeks

Group Type: EXPERIMENTAL

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

Intervention Type: PROCEDURE

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

medical ozone

Intervention Type: DRUG

10 ml of medical ozone

Interventions

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

Intervention Type: PROCEDURE

methylprednisolone acetate and lidocaine

40 mg methylprednisolone acetate and 1 mL lidocaine

Intervention Type: DRUG

PRP and lidocaine

3 mL PRP and 1 mL lidocaine

Intervention Type: DRUG

medical ozone

10 ml of medical ozone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• One hundred and five patients, ASA physical status I - III, age 21 - 65 years, diagnosed with sacroiliitis.

Exclusion Criteria

• • Patient refusal

• Psychological disturbance.
• Local skin infection at the site of injection.
• Ozone allergy
• Coagulation disorders.
• Chronic opioid use.
• Sacroiliitis associated with disk pathology.
• Severe ankylosing spondylitis.
• History of corticosteroid injection within last three months.
• Uncontrolled concomitant medical condition.
• Severe arrhythmia, hypertensive crisis and other cardiovascular diseases.
• Pregnant women.
• Bowel inflammatory disease.
• Psoriasis

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdelnaby Ibrahim

Ahmed elmaghrapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University hospitals

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed An Ibrahim

Role: CONTACT

amer.soliman0@gmail.com

01092939382

Facility Contacts

Ahmed Ab Ibrahim

Role: primary

amer.soliman0@gmail.com

01092939382

Other Identifiers

36264MD46/3/23

Identifier Type: -

Identifier Source: org_study_id